ID

35694

Beschreibung

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Stichworte

Versionen (2)
  1. 12.03.19 12.03.19 -
  2. 15.03.19 15.03.19 -
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GlaxoSmithKline

Hochgeladen am

15. März 2019

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Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)

Englisch

Visit 1 - Demographics; General Medical History; Laboratory Tests; Baseline Assessment; General Symptoms Observed Just Before Injection

1 Formulare  
Administration
Beschreibung

Administration

Alias
UMLS CUI-1
C1320722
Centre
Beschreibung

Centre

Datentyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit
Beschreibung

Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Informed Consent date:
Beschreibung

I certify that Informed Consent has been obtained prior to any study procedure.

Datentyp

date

Alias
UMLS CUI [1]
C2985782
Demographics
Beschreibung

Demographics

Alias
UMLS CUI-1
C1704791
Subject initials - First name
Beschreibung

Subject initials - First name

Datentyp

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
UMLS CUI [2]
C1443235
Subject initials - Family Name
Beschreibung

Subject initials - Family Name

Datentyp

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
UMLS CUI [2]
C1301584
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Race
Beschreibung

Race

Datentyp

text

Alias
UMLS CUI [1]
C0034510
If other race, please specify
Beschreibung

If other race, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Eligibility
Beschreibung

Eligibility

Alias
UMLS CUI-1
C0013893
Is the subject eligible for the study, according to the criteria listed hereby?
Beschreibung

If no, please give the corresponding criterion number(s)

Datentyp

boolean

Alias
UMLS CUI [1]
C0013893
Corresponding criterion number(s)
Beschreibung

Corresponding criterion number(s)

Datentyp

text

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0237753
Investigator Signature:
Beschreibung

Investigator Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
General Medical History / Physical Examination
Beschreibung

General Medical History / Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any relevant medical history/medical condition?
Beschreibung

Please tick appropriate box and give diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0012634
Medical Condition
Beschreibung

Medical Condition

Alias
UMLS CUI-1
C0012634
Diagnosis
Beschreibung

Diagnosis

Datentyp

integer

Alias
UMLS CUI [1]
C0011900
Status
Beschreibung

Status

Datentyp

integer

Alias
UMLS CUI [1]
C0449438
Medical Condition
Beschreibung

Medical Condition

Datentyp

text

Alias
UMLS CUI [1]
C0012634
Laboratory Tests
Beschreibung

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Beschreibung

Has a blood sample been taken

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Baseline Temperature
Beschreibung

Baseline Temperature

Alias
UMLS CUI-1
C0005903
UMLS CUI-2
C1442488
Temperature:
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Route
Beschreibung

Route

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1515974
Baseline Assessment - General Symptoms
Beschreibung

Baseline Assessment - General Symptoms

Alias
UMLS CUI-1
C1442488
UMLS CUI-2
C1516048
UMLS CUI-3
C0159028
Does the subject experience any of the following general solicited signs or symptoms just before injection?
Beschreibung

Does the subject experience any of the following general solicited signs or symptoms just before injection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C1533685
UMLS CUI [1,3]
C0332152
General Symptoms Observed Just Before Injection
Beschreibung

General Symptoms Observed Just Before Injection

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C1533685
UMLS CUI-3
C0332152
Symptom
Beschreibung

Only for children from 1 to 5 Years old

Datentyp

integer

Alias
UMLS CUI [1]
C1457887
Intensity
Beschreibung

Intensity

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
General Symptoms Observed Just Before Injection
Beschreibung

General Symptoms Observed Just Before Injection

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C1533685
UMLS CUI-3
C0332152
Symptom
Beschreibung

Only for Children from 6 to 11 Years old

Datentyp

integer

Alias
UMLS CUI [1]
C1457887
Intensity
Beschreibung

Intensity

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
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Ähnliche Modelle

Visit 1 - Demographics; General Medical History; Laboratory Tests; Baseline Assessment; General Symptoms Observed Just Before Injection

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Centre
Item
Centre
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit
Item
Visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Informed Consent date
Item
Informed Consent date:
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Subject initials - First name
Item
Subject initials - First name
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C1443235 (UMLS CUI [2])
Subject initials - Family Name
Item
Subject initials - Family Name
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C1301584 (UMLS CUI [2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
Gender
Code List
Gender
CL Item
Female (F)
CL Item
Male (M)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (WH)
CL Item
Black (BL)
CL Item
Oriental (OR)
CL Item
OT (please specify) (Other)
If other race, please specify
Item
If other race, please specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Eligibility
C0013893 (UMLS CUI-1)
Is the subject eligible for the study, according to the criteria listed hereby
Item
Is the subject eligible for the study, according to the criteria listed hereby?
boolean
C0013893 (UMLS CUI [1])
Corresponding criterion number(s)
Item
Corresponding criterion number(s)
text
C1516637 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator Signature:
text
C2346576 (UMLS CUI [1])
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Are you aware of any relevant medical history/medical condition
Item
Are you aware of any relevant medical history/medical condition?
boolean
C0262926 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Item Group
Medical Condition
C0012634 (UMLS CUI-1)
Item
Diagnosis
integer
C0011900 (UMLS CUI [1])
Diagnosis
Code List
Diagnosis
CL Item
Cutaneous (10)
CL Item
Eyes (5)
CL Item
Ears-Nose-Throat (6)
CL Item
Cardiovascular (2)
CL Item
Respiratory (3)
CL Item
Gastrointestinal (1)
CL Item
Musculo-Skeletal (7)
CL Item
Neurological (8)
CL Item
Genito-Urinary (12)
CL Item
Haematology (11)
CL Item
Allergies (4)
CL Item
Endocrine (9)
CL Item
Other (specify) (99)
Item
Status
integer
C0449438 (UMLS CUI [1])
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Medical Condition
Item
Medical Condition
text
C0012634 (UMLS CUI [1])
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Has a blood sample been taken
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Item Group
Baseline Temperature
C0005903 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Temperature
Item
Temperature:
float
C0005903 (UMLS CUI [1])
Item
Route
integer
C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
Axillary (1)
CL Item
Oral (applicable for all ages) (2)
CL Item
Rectal (applicable to 1 to 5 years old) (3)
Item Group
Baseline Assessment - General Symptoms
C1442488 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
C0159028 (UMLS CUI-3)
Does the subject experience any of the following general solicited signs or symptoms just before injection
Item
Does the subject experience any of the following general solicited signs or symptoms just before injection?
boolean
C0159028 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item Group
General Symptoms Observed Just Before Injection
C0159028 (UMLS CUI-1)
C1533685 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Item
Symptom
integer
C1457887 (UMLS CUI [1])
Symptom
Code List
Symptom
CL Item
Irritability/ Fussiness (1)
CL Item
Drowsiness (2)
CL Item
Loss of appetite (3)
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item Group
General Symptoms Observed Just Before Injection
C0159028 (UMLS CUI-1)
C1533685 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Item
Symptom
integer
C1457887 (UMLS CUI [1])
Symptom
Code List
Symptom
CL Item
Headache (1)
CL Item
Fatigue (2)
CL Item
Gastrointestinal symptoms (3)
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
1  (1)
CL Item
2  (2)
CL Item
3 (3)
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